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Mink Therapeutics’ Agent-797 Drives Durable Cancer Remission
Mink Therapeutics reported a remarkable clinical response wherein a testicular cancer patient achieved complete remission following administration of their off-the-shelf invariant natural killer...
CRISPR Guide RNA Efficiency Varies with Ancestry, Risks Off-target Effects
A study led by the Broad Institute and Dana-Farber Cancer Institute revealed that CRISPR-Cas9 gene editing guide RNAs have varied efficiency depending on the ancestry of the cancer cell lines,...
Ultragenyx Gene Therapy Faces FDA Hurdles: Manufacturing Issues Trigger CRL
Ultragenyx Pharmaceutical has encountered a regulatory setback as the FDA issued a complete response letter (CRL) for its gene therapy UX111 aimed at treating Sanfilippo syndrome type A, a rare...
AstraZeneca’s Baxdrostat Validates $1.8B CinCor Bet With Phase III Win
AstraZeneca reported positive Phase III results for baxdrostat, an aldosterone synthase inhibitor targeting uncontrolled and treatment-resistant hypertension. The trial met all primary and...
Takeda Advances Narcolepsy Treatment With Dual Phase III Trial Success
Takeda Pharmaceutical announced positive outcomes from two Phase III clinical trials for oveporexton, an oral orexin receptor 2-selective agonist in narcolepsy type 1. The studies met all primary...
Waters Corp to Acquire BD’s Biosciences & Diagnostics in $17.5 Billion Deal
Waters Corporation announced plans to merge with the Biosciences and Diagnostic Solutions unit of Becton, Dickinson & Co. in a transaction valued at $17.5 billion, marking the largest life...
Innovative RNA Manufacturing Partnership Targets Personalized Cancer Therapeutics
Elegen and Nutcracker Therapeutics launched a pilot program integrating their platforms to enable industry-first fully synthetic, cell-free manufacturing of RNA-based personalized cancer...
FDA Launches Transparency Initiative by Publishing Drug Rejection Letters
In a move toward regulatory openness, the FDA released over 200 complete response letters (CRLs) corresponding to drug application denials, marking a step in the agency's modernization and...
AI-powered Optogenetic Screening Platform Accelerates Drug Discovery
Integrated Biosciences unveiled a novel optogenetic screening platform combining programmable light-activation with high-throughput compound testing, enabling precise interrogation of biological...
China Biotech Licensing Gains Traction in US Market Amid Pricing Pressures
A Jefferies report highlights significant growth in licensing deals from Chinese biotech companies to multinational pharmaceutical firms, with China now accounting for 32% of outlicensing deal...
New Biomarkers and Mechanisms in Neurodegenerative Disease Research
Recent studies uncover advancements in Alzheimer's and Parkinson's disease diagnostics and biology. Circular Genomics and Washington University developed a circular RNA biomarker signature,...
Industry Consolidation and Financing Activity in Biotech and Med-Tech
The biotech and med-tech sectors report significant financial and managerial movements. PCI Pharma Services secured private equity funding valuing the CDMO at $10 billion, backed by Bain Capital,...
FDA rejects Ultragenyx gene therapy: Manufacturing issues stall Sanfilippo treatment
The FDA has issued a complete response letter rejecting Ultragenyx's gene therapy UX111 for Sanfilippo syndrome type A due to manufacturing deficiencies observed during facility inspections....
AstraZeneca’s hypertension drug baxdrostat wins phase III trial, validates CinCor acquisition
AstraZeneca reported positive Phase III results for baxdrostat, an aldosterone synthase inhibitor targeting uncontrolled and treatment-resistant hypertension. The trial demonstrated significant...
Takeda’s oral orexin agonist cleares dual Phase III in narcolepsy, filing planned
Takeda’s orexin receptor 2-selective agonist, oveporexton (formerly TAK-861), met all primary and secondary endpoints in two registrational Phase III trials for narcolepsy type 1. The oral therapy...
Waters to merge with BD’s biosciences unit in $17.5 billion deal to expand life sciences reach
Waters Corporation and Becton, Dickinson & Co. (BD) announced a $17.5 billion transaction to combine Waters with BD’s Biosciences and Diagnostic Solutions business. The merger will nearly double...
Sonnet BioTherapeutics pivots to crypto under $888 million deal, becoming Hyperliquid Strategies
Sonnet BioTherapeutics announced a definitive agreement to transform via a $888 million business combination with Rorschach I LLC, affiliated with Atlas Merchant Capital and Paradigm Operations....
Nutcracker and Elegen unveil cell-free RNA manufacturing platform for personalized cancer therapies
Nutcracker Therapeutics and Elegen launched a pilot program demonstrating the industry's first fully synthetic, cell-free manufacturing platform for RNA-based personalized cancer therapeutics...
Ancestry bias skews CRISPR screens, missing critical cancer drug targets
Researchers from the Broad Institute and Dana-Farber Cancer Institute identified that CRISPR-Cas9 guide RNA efficiency varies by ancestry, with off-target effects occurring more frequently in cell...
Viome and Scripps partner to develop non-invasive RNA test for early colon cancer detection
Personalized medicine company Viome Life Sciences and Scripps Research have initiated a collaboration to develop and clinically validate an at-home RNA-based screening test for colorectal cancer...